Clinical trial · Observational
Secondary Lymphedema Due to Human Adjuvant Disease
Human Adjuvant Disease as a Cause of Secondary Lower Extremity Lymphedema
NCT04588493CI-TRIAL-00047686completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This observational, descriptive, retrospective study the clinical and imaging findings of 10 lower legs of 5 patients with previous history of injection of modeling substances for cosmetic purposes at buttocks and hips ande developed lower limb edema. Lower limb lymphedema index and lymphoscintigraphy findings were evaluated and reported.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Granuloma, Foreign-Body | — | UNRESOLVED | — |
| Lymphedema of Leg | — | UNRESOLVED | — |
| Lymphedema, Secondary | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lower extremity Lymphoscintigraphy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Transport Index
- timeFrame
- 4 months
- description
- Transport index in each pelvic limb: transport kinematics, distribution pattern, index time for the appearance of regional lymph nodes, number and collection of colloids in lymph nodes and presence and quality of the colloid uptake by the lymphatic vessels. Summation of these five components resulted in the transport index, which could range from 0 to 45 points; less than 5 means a normal study, higher scores represent abnormal or pathological results
Secondary outcomes (1)
- measure
- Lower extremity lymphedema index
- timeFrame
- 4 months
- description
- For Lower extremity lymphedema (LEL) index we first added up cross-sectional areas of the extremities in 5 parts where circumferences were measured, making an approximation that the cross-sections are perfect circles. We made use of the sum of the cross-sectional area's property of being proportional to the sum of the square of the circumference to simplify the calculation of the formula. Finally, we divided the number by BMI to make corrections for the body type, and the obtained value was defined as the LEL index. Dividing the sum by BMI corrected the index according to the body type. LEL index \< 250 corresponded to LEL stage I, 250 to 300 corresponded to LEL stage II, 300 to 350 corresponded to LEL stage III, and \> 350 corresponded to LEL stage IV
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Both sex * Over 18 years old * History of injection of modelling substances for cosmetic purposes * History of lower limb edema Exclusion Criteria: * History of primary lower limb lymphedema * Reject to participate * Confirmed other causes of edema
References
Publications (0)
Data not yet available
No reference posted for this study.